Pilot Tape Harvesting Study
A Pilot Study to Evaluate Using Tape Harvesting to Collect Ribonucleic Acid From the Upper Epidermis of Healthy Volunteers and Subjects With Discoid Lupus, Subjects With Subacute Cutaneous Lupus, and Subjects With Atopic Dermatitis
1 other identifier
observational
37
1 country
2
Brief Summary
The main objectives of the study are: To determine if RNA recovery from tape harvesting allows for the identification of a disease gene signature (e.g., interferon \[IFN\] signature for lupus) or other biomarkers that may differentiate affected from normal or unaffected skin; To determine if the lupus gene signature is differentially expressed in the epidermis from active discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE) lesions when compared with unaffected skin from the same participants and from the skin of healthy volunteers (HVs); To determine if the atopic dermatitis (AD) gene signature is differentially expressed in the epidermis from active AD lesions when compared with unaffected skin from the same participants and from the skin of HVs; and To correlate the levels of transcripts of targeted genes in the skin by tape harvesting with those obtained from the blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 28, 2016
September 1, 2016
2.3 years
April 25, 2014
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
RNA expression of genes suspected to be associated with skin disease in affected versus unaffected skin in participants with skin disease
Participants with skin disease include participants affected with cutaneous lupus erythematosus (\[CLE\] i.e., DLE or SCLE), SCLE, AD
Day 1
RNA expression of genes suspected to be associated with skin disease in healthy skin from HVs versus affected skin from participants with skin disease
Day 1
Comparison of RNA expression of genes suspected to be associated with skin disease in healthy skin from HVs versus unaffected skin from participants with skin disease
Day 1
Correlation between expression levels obtained from tape harvesting and those obtained from blood samples for each identified gene
Day 1
Study Arms (3)
Healthy Volunteers
Skin taping; blood sampling; optional biopsy
Cutaneous lupus erythematosus
This group consists of participants affected with lupus (DLE, SCLE). Skin taping; blood sampling; optional skin biopsy (DLE participants); required skin biopsy (SCLE participants)
Atopic dermatitis
Skin taping; blood sampling; optional skin biopsy
Interventions
Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)
Sampling for biomarker and basic research in CLE and AD
As described in the treatment arm
Eligibility Criteria
Participants are enrolled at selected investigational sites in a standard clinical practice setting
You may qualify if:
- Healthy volunteers must be in good overall health as determined by the Investigator, based on medical history, physical examination (per standard dermatology practice), and vital signs.
- Subjects with lupus must present with active DLE or SCLE skin disease (with or without systemic manifestations of SLE, as defined by ≥4 out of 11 classification criteria for SLE).
- Subjects with AD must have been diagnosed by the Eichenfield revised criteria of Hanifin and Rajka, disease duration for at least 2 years before Screening and disease activity defined as Investigator's Global Assessment (IGA) score ≥3 at screening
You may not qualify if:
- History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by tape harvesting (e.g., allergy to adhesives).
- Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
- History of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses
- Evidence of skin conditions other than DLE or SCLE at the Day 1 Visit that, in the opinion of the Investigator, would interfere with the study execution or analysis.
- Evidence of skin conditions other than AD at the Day 1 Visit that, in the opinion of the Investigator, would interfere with the study execution or analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (2)
Research Site
Boston, Massachusetts, 02111, United States
Research Site
Boston, Massachusetts, 02115, United States
Biospecimen
Specimens collected from skin taping and blood sampling.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2014
First Posted
April 29, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 28, 2016
Record last verified: 2016-09